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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203013
Company: ALEMBIC

Products on ANDA 203013

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	AB	No	No
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203013

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2018	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2025	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/29/2025	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/07/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/03/2023	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
10/03/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/03/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203013

BUPROPION HYDROCHLORIDE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	203013	ALEMBIC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	076143	APOTEX
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	075491	AUROBINDO PHARMA USA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	208606	CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	206975	HERITAGE PHARMA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	207403	MICRO LABS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	No	AB	075584	SENORES PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	203013	ALEMBIC
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	076143	APOTEX
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075491	AUROBINDO PHARMA USA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	208606	CADILA PHARMS LTD
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	206975	HERITAGE PHARMA
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	207403	MICRO LABS
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	075584	SENORES PHARMS

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